Federal Register #PTO-P-2026-0499

USPTO Grants One-Year Interim Patent Extension for Centanafadine Hydrochloride

This notice announces a regulatory action by the United States Patent and Trademark Office (USPTO) regarding a pharmaceutical patent: - The USPTO, under the Department of Commerce, has granted a one-year interim extension for U.S. Patent No. 8,461,196 - The patent covers the drug product Centanafadine Hydrochloride - The extension is issued under 35 U.S.C. 156(d)(5) due to ongoing FDA regulatory review for commercial marketing approval - Otsuka Pharmaceutical Co., Ltd. is the OEM and agent for the patent owner, Otsuka America Pharmaceutical, Inc. - No procurement of products or services is involved; this is a regulatory extension of patent rights - The extension allows the patent to remain in force for one additional year beyond its original expiration date - This action highlights the USPTO's role in managing patent term extensions for pharmaceutical products under regulatory review

Description

The United States Patent and Trademark Office has issued an order granting a one-year interim extension of the term of U.S. Patent No. 8,461,196 related to Centanafadine Hydrochloride. This extension is granted under 35 U.S.C. 156(d)(5) due to an ongoing regulatory review period before the Food and Drug Administration. The extension is for one year from the original expiration date of the patent, which is July 25, 2026. The notice is part of the Federal Register's publication of patent and trademark actions.

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